MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADAPTAO INTRAOCULAR LENS

Model Number	ADAPTAOP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested of the reporter, the device has not been returned for evaluation.A review of the device history record (dhr), did not find any anomalies or nonconformities related to the reported event.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information a root cause of the event could not be conclusively determined.
Event or Problem Description
It was reported that after the implantation of an intraocular lens (iol) into the right eye (od), the capsular bag became unstable and broke.The iol was cut and removed from eye, and a successful intraoperative lens replacement using a lens of an unknown model was completed.The patient's outcome is good.
Additional Manufacturer Narrative
Device was received and evaluated.Microscopic examination was performed and found the device cut in 2 pieces across the optic.Only one half of the device was returned.Based on the available information the cause of this event could not be determined.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 16743044
• Report Number: 0001313525-2023-70048
• Device Sequence Number: 17776935
• Product Code: HQL
• UDI-Device Identifier: 10757770501936
• UDI-Public: (01)10757770501936(17)250831
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: ADAPTAOP
• Device Catalogue Number: AO60P1400
• Device Lot Number: 1265301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male